8145--Medication Return Envelopes (VA-24-00012799)

urn in/mail in unused medications to designated sites. The VA has a similar type of program that was initiated in 2014. As of 8/31/2023, Veterans have returned over 390 Tons of unneeded/unwanted medication using VA approved medication return envelopes and onsite receptacles. The Department of Veterans Affairs Consolidated Mail Outpatient Pharmacy (CMOP) supporting multiple VA Medical Centers throughout the United States and Territories is seeking information on the following project: VA Pharmaceutical Mail-Back Program. The North American Classification System (NAICS) code for this acquisition is 339113 (750 employees). This Sources Sought Notice is part of market research and will be used to make appropriate acquisition decisions including whether the procurement warrants a set-aside for Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), or Small Business (SB). Description of Services: This non-personal services requirement is for the purchase, bulk storage, delivery, postage, processing, destruction, and reporting of Medication Return Envelopes and their contents. Contractor must have a signed service agreement with the United States Postal Service (USPS) prior to submitting a bid and must maintain that agreement throughout the life of the contract. Contractor shall distribute envelopes to VA Medical Centers (VAMC s) or other facilities that will be identified on each monthly order. The envelope system must meet the Veterans Health Administration (VHA) procedures for shipping and privacy of the Veterans information. The Contractor shall setup a VA approved electronic ordering system that will accept, track and confirm delivery of all orders from VA sites. The Contractor shall receive, process and destroy medication at the address listed on the envelope and must be an approved Drug Enforcement Administration (DEA) Registered Reverse Distributor and Collector. Reporting of destruction will be done on a quarterly basis for each envelope and per VA site. Information shall include, but is not limited to, package weight, poundage per ordering site and total poundage each month. Capabilities and Operating Requirements The Contractor must be registered with the DEA as a collector and meet all the requirements defined in the DEA regulations for operation of a mail-back program to include (but not limited to): The Contractor shall not employ, as an agent or employee who has access to or influence over controlled substances, any person who has been convicted of any felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or suspended, or has surrendered a DEA registration for cause. Per the regulations, for cause means in lieu of, or as a consequence of, any Federal or State administrative, civil, or criminal action resulting from an investigation of the individual s handling of controlled substances. The Contractor must store sealed mail-back packages collected at the registered location in a securely locked, substantially constructed cabinet or a securely locked room with controlled access. Maintaining all records applicable under the regulations for DEA registrants operating a mail-back program. The envelope shall be nondescript and shall not include any markings or other information that might indicate that the package contains controlled substances The envelope shall be water- and spill-proof; tamper-evident; tear-resistant; and sealable The envelope shall be preaddressed with and delivered to the collector s registered address. The cost of shipping the envelope shall be postage paid. The envelope shall have a unique identification number that enables the package to be tracked. The envelope shall include instructions for the user that indicate the process for mailing back the package, the permitted substances that can be sent, notice that packages may only be mailed from within the customs territory of the United States (the 50 States, the District of Columbia, and Puerto Rico), and notice that only packages provided by the collector will be accepted for destruction. Upon receipt of a mail-back package by the Contractor the package shall not be opened, x-rayed, analyzed, or otherwise penetrated. If the Contractor ceases an authorized mail-back program the Contractor will: (i) Make a reasonable effort to notify the public prior to ceasing the authorized mail-back program; and (ii) Obtain the written agreement of another collector that has and utilizes at its registered location a method of destruction consistent with DEA regulations to receive all remaining mail-back packages that were disseminated but not returned and arrange for the forwarding of only such packages to that location. Use an on-site method of destruction sufficient to render all such controlled substances non-retrievable. Per the regulations On-site means located on or at the physical premises of the registrant s registered location. A controlled substance is destroyed on-site when destruction occurs on the physical premises of the destroying registrant s registered location. The Contractor will use destruction methods that are in compliance with all applicable EPA and local State regulation. The Contractor will use the United States Postal Service (USPS) as the common carrier for mail-back envelopes and be able to demonstrate the shipping process is approved by USPS as an acceptable method of shipping at the time of contract award. Veteran shall place the collection envelope filled with unwanted pharmaceuticals into a United states Postal Service (USPS) approved mailbox or Office. The Contractor shall only use USPS as a postal transport entity for this acquisition. Pick up the envelopes from Veterans' homes or convenient USPS drop off locations. USPS postal transport service shall deliver sealed collection envelope to the address of listed on the envelope. Must meet the regulatory requirements as outline in 21 CFR Part 1317 located at https://www.deadiversion.usdoj.gov/21cfr/cfr/1317/subpart_b.htm#70 §1317.70 Mail-back programs. (a) A mail-back program may be conducted by Federal, State, tribal, or local law enforcement or any collector. A collector conducting a mail-back program shall have and utilize at their registered location a method of destruction consistent with §1317.90 of this chapter. (b) Only those controlled substances listed in Schedule II, III, IV, or V that are lawfully possessed by an ultimate user or person lawfully entitled to dispose of an ultimate user decedent's property may be collected. Controlled and non-controlled substances may be collected together and be comingled, although comingling is not required. (c) Collectors or law enforcement that conduct a mail-back program shall make packages available (for sale or for free) as specified in this paragraph to ultimate users and persons lawfully entitled to dispose of an ultimate user decedent's property, for the collection of controlled substances by common or contract carrier. Any person may partner with a collector or law enforcement to make such packages available in accordance with this section. The packages made available shall meet the following specifications: (1) The package shall be nondescript and shall not include any markings or other information that might indicate tha